The European Union's drugs regulator on Thursday recommended approval of Eisai and Biogen's Leqembi for some patients with early Alzheimer's disease, reversing its initial decision from four months ago.

A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.

Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | Upon reexamination, the EMA has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi.

Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved.

The EU's drugs regulator recommends approval of Eisai and Biogen's Alzheimer's drug, Leqembi, for patients with early stages of the disease. The approval is limited to those with certain genetic profiles.

Longer-term, Eisai and Biogen are hoping for further evidence to support Leqembi from the phase 3 AHEAD 3-45 trial, which started in 2020 and is underway in Japan, the US, and Europe and is enrolling people ages 55-80 who have not been diagnosed with Alzheimer's or another form of dementia. Results are due in 2028.

The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with early Alzheimer's disease, months after the agency first rejected the treatment.

The EU's drugs regulator has recommended approval for Leqembi, a treatment by Eisai and Biogen, for early Alzheimer's disease. This could position it as the EU’s first treatment for the condition. The decision follows a re-evaluation,